CSPI Calls for Replacement of Member of Breast Implant PanelStatement of CSPI Integrity in Science Project Director Merrill Goozner

As The Washington Post reported in 2003, Dr. Michael Miller has taken $25,000 from breast-implant maker Inamed to help produce an educational CD-ROM about breast reconstruction surgery. We are extremely disappointed that the FDA chose to overlook this conflict of interest. It's also distressing that the panel is so unbalanced by the inclusion of four plastic surgeons, who financially benefit from the use of these devices. As the chairman of the last committee wrote to FDA chairman Mark McClellan after that vote, "It just does not play well in Peoria."

The Federal Advisory Committee Act requires that committees be balanced with regards to points of view. With plastic surgeons constituting four of 12 voting members on this committee, their votes may once again determine the outcome of the vote. The imbalance is exacerbated by the fact that only one person on the committee is expert in the diseases that may result from ruptured silicon gel breast implants.

By refusing to name different people to sit on the committee, the FDA has created a situation where the final vote next week will inevitably be clouded by the perception that some members had a conflict of interest that may have influenced their vote.

Last month, a dozen citizens' organizations and health advocacy groups urged the FDA to adopt new rules banning all scientists or clinicians from sitting on committees where they have direct conflicts of interest with manufacturers whose products are under discussion. The FDA's failure in this first major test to follow that advice will further undermine the public's faith in the credibility of its advisory committee process and, ultimately, in its regulatory decisions.